Kornimate/medical-research-clean huggingface dataset:
acute pain caused by paclitaxel in patients with cancer

Conditions: Chemotherapeutic Agent Toxicity; Neurotoxicity; Pain; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: gathering information over time from patients receiving paclitaxel for cancer may help doctors learn more about pain caused by paclitaxel and plan the best treatment. purpose: this clinical trial is studying acute pain caused by paclitaxel in patients with cancer.

objectives: * to describe the incidence and characteristics of and change in pain related to paclitaxel infusions over several courses in patients receiving paclitaxel weekly or every 2-4 weeks with or without neurotoxic chemotherapy. * to investigate the association between paclitaxel-induced acute pain syndrome symptoms and eventual chemotherapy-induced neuropathy. * to perform exome-sequencing analysis and identify genetic variants that predict paclitaxel- induced peripheral neuropathy. * to identify clinical phenotypes associated with paclitaxel toxicity (i.e., acute pain syndrome and neuropathy). * to explore whether there are any evident differences between results seen in the majority caucasian population and the minority populations. outline: this is a multicenter study. patients are grouped according to paclitaxel dosing schedule (weekly vs every 2-4 weeks) and concurrent use of neurotoxic agent (yes vs no). blood samples are collected at baseline for correlative laboratory studies, including genetic biomarker and polymorphism studies.

Eligibility criteria:
disease characteristics: * diagnosis of cancer * planning to receive paclitaxel iv (excluding paclitaxel albumin-stabilized nanoparticle formulation \[nab-paclitaxel\]) according to one of the following dosing schedules: * at least 175 mg/m\^2 at 2-4 week intervals (course duration of 2, 3, or 4 weeks, respectively) * 70-90 mg/m\^2 weekly (3 out of 4 weeks allowed) patient characteristics: * ecog performance status 0-1 * life expectancy \> 6 months * able to complete questionnaires (alone or with assistance) * willing to provide required biological specimens * no prior or concurrent peripheral neuropathy (from diabetes or other causes) * no prior or concurrent fibromyalgia prior concurrent therapy: * see disease characteristics * no prior paclitaxel or neurotoxic chemotherapy drugs, including other taxanes, platinum agents, vinca alkaloids, or epothilones * no concurrent neutrophil colony-stimulating factor therapy

Keywords: pain neurotoxicity chemotherapeutic agent toxicity unspecified adult solid tumor, protocol specific
aspirin resistance and prognosis of patients with critical limb ischaemia

Conditions: Aspirin Resistance

Summary: acetylsalicylic acid (aspirin, asa) is the most widely prescribed drug used in primary and secondary prevention of cardiovascular disease. however, aspirin resistance has been described, mostly in cardiac patients and is an independent predictive factor for a poor survival. two frequent conditions in patients with cardiovascular diseases, diabetes and hypercholesterolemia, are also considered as risk factors for aspirin resistance. among patients with peripheral arterial disease, those with critical limb ischemia have the worst cardiovascular prognosis. at one year, 23% are dead, 25% have a major cardiovascular event and 25% have a major amputation (which can be combined). aspirin resistance is poorly studied in these patients, and to our knowledge no study has been made to assess the prognosis value of aspirin resistance on cardiovascular outcomes in critical limb ischaemia patients. hospitalized critical limb ischaemia patients will be tested for aspirin resistance using the bed-side point of care verifynow®, and will be followed during one year, including death, fatal and non-fatal acute coronary syndromes, cardiac decompensation, stroke, and major amputation.


Eligibility criteria:
inclusion criteria: * any adult patient hospitalized for critical limb ischaemia and already treated by aspirin for at least 4 days before the verifynow® test. critical limb ischemia is defined by the tasc ii criteria : chronic ischemic rest pain, ulcers or gangrene attributable to objectively proven arterial occlusive disease, confirmed by an ankle pressure subordinate or equal 50 mmhg and a toe pressure subordinate or equal 30 mmhg, or a transcutaneous oxygen tension subordinate or equal 30 mmhg exclusion criteria: * non observance to aspirin treatment, other drugs that could interact with platelets (nsaids, other anti-platelet agents), other peripheral vascular disease status than critical limb ischemia, acute limb ischemia, platelet number lower than 100 000/mm3, hematocrit lower than 29%, known primary hemostasis disorder.

Keywords: critical limb ischaemia aspirin resistance
iptacopan in patients with anca associated vasculitis

Conditions: Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis

Summary: the purpose of this study is to evaluate the efficacy and safety of iptacopan compared to standard of care (soc) to induce and maintain remission in study participants with active granulomatosis with polyangiitis (gpa) or microscopic polyangiitis (mpa), when used in combination with rituximab (rtx) induction. the trial will also assess the impact of iptacopan on disease relapses, evolution of renal function and proteinuria, gc side effects, patients' immune status, and qol.

this is a randomized, controlled study to evaluate the efficacy and safety of iptacopan in combination with rtx induction therapy for the treatment of newly diagnosed or relapsed patients with active gpa or mpa.

Eligibility criteria:
inclusion criteria: * newly diagnosed or relapsed gpa and mpa (according to the 2022 acr/eular classification criteria for gpa and mpa) requiring treatment with rtx and gc as per investigator's judgement. * bvas assessment with ≥1 major item, or ≥3 minor items, or ≥2 renal items at screening. * positive antibody test for anti-proteinase 3 (pr3) or anti-myeloperoxidase (mpo) antibodies at screening or with history of documented evidence of a positive antibody test. exclusion criteria: * other systemic disease which constitutes the primary illness, including but not limited to: eosinophilic granulomatosis with polyangiitis (egpa), moderate to severe systemic lupus erythematosus, iga vasculitis (purpura schönlein-henoch), rheumatoid vasculitis, sjögren's syndrome, anti-glomerular basement membrane (gbm) disease, cryoglobulinemic vasculitis, autoimmune hemolytic anemia, autoimmune lymphoproliferative syndrome or mixed connective tissue disease. * alveolar hemorrhage requiring invasive pulmonary ventilation support at screening. * severe kidney disease defined as estimated glomerular filtration rate (egfr) \<15 ml/minute/1.73m2, or kidney failure defined as receiving renal replacement therapy such as hemo(dia)filtration, hemo-/peritoneal dialysis, or having received a kidney transplant. * received plasma exchange/-pheresis within 12 weeks prior to screening.

Keywords: anca-associated vasculitis; granulomatosis with polyangiitis (gpa); microscopic polyangiitis (mpa); lnp023 (iptacopan).
whole-body vibration versus gravity force stimulation on postural stability in children with down syndrome

Conditions: Down Syndrome

Summary: the purpose of the study is to compare the effect between of whole-body vibration and gravity force stimulation on postural stability in children with down syndrome.

down syndrome (ds) is one of genetic disorders characterized by some common clinical and functional features. most children with down syndrome have deficits in postural stability or balance, co-ordination, gait, and functional mobility throughout childhood and adulthood. postural control dysfunctions are the most common problems found in children with ds leads them to be more inactive, which contributes to functional mobility problems. several techniques that involve proprioceptive, vestibular, and visual inputs are so beneficial to children with ds. whole-body vibration (wbv) is one of the training methods that use high-frequency mechanical stimuli generated by a vibrating platform and transmitted through the body, leading to bone loading and sensory receptor stimulation. gravity force stimulation (gfs) has a strong impact on the child's sensory system helping to normalize the system through exercises that send strong messages to the brain to regulate the tactile, proprioceptive and vestibular components. hence, there is need to compare between the effects of whole-body vibration training and gravity force stimulation on postural stability in children with down syndrome.

Eligibility criteria:
inclusion criteria: 1. children ages will be ranged from 8 to 10 years old. 2. functional hearing and vision. 3. mild and moderate mental retardation with iq level (50-70) determined by a psychiatric specialist in the school (iq measured by stanford-binet intelligence scale) 4. independent standing and walking. exclusion criteria: 1. synptomatic pain. 2. musculoskeletal problems or/ atlanto-axial instability. 3. rheumatic and congenital heart disease 4. history of previous surgical operation 5. regular participation in any sport activities.

Keywords: whole-body vibration gravity force stimulation biodex balance system down syndrome
rfc and mthfr snps & hent1- dck expression as prognostic factors in all & hent1- dck expression as prognostic factors in aml

Conditions: Acute Lymphoblastic Leukemia.; Acute Myeloblastic Leukemia

Summary: results of actual treatment in all are not optimal. new prognostic factors, which may determine clinical \& molecular response are required. hyper-cvad is an internationally accepted schema for such patients. the objective of this pilot study is to evaluate polymorphisms regarding rfc (reduced folate carrier) and mthfr enzyme, which may affect the function of these proteins, and therefore the intracellular bioavailability of methotrexate. also, the expression levels of hent1 and dck will be evaluated, since such genes codify for citarabine intracellular transport and activation, respectively. clinical characteristics will be tabulated and analyzed for responders \& non-responders patients. uni- \& multivariate analysis will be done to evaluate factors influencing on response and survival.


Eligibility criteria:
inclusion criteria: * age: older than 15 years. * male, female. * normal renal \& liver functions. * without previous treatment. * candidate to be treated with hypercvad schema (all patients). * candidate to receive induction remission with cytarabine (aml patients) exclusion criteria: * patients not candidate to receive methotrexate or cytarabine.

Keywords: acute lymphoblastic leukemia prognostic factor pharmacogenetics.
drug and dose adjustment in preventing postoperative nausea and vomiting

Conditions: Postoperative Nausea and Vomiting

Summary: the aim is to evaluate the effectiveness of different regimens of prophylactic ondansetron, dexamethasone, or both, on the incidence and severity of post-operative nausea and vomiting.

patients will be randomized to one of four arms: ondansetron (4o-pe: 4 mg ondansetron pre-emergence, 8o-pe: 8 mg ondansetron pre-emergence, 4o-pi: 4 mg ondansetron pre-incision, 8o-pi: 8 mg ondansetron pre-incision), dexamethasone (4d-pe: 4 mg dexamethasone pre-emergence, 8d-pe: 8 mg dexamethasone pre-emergence, or 4d-pi: 4 mg dexamethasone pre-incision, or 8d-pi: 8 mg dexamethasone pre-incision), combination therapy group (4o-pi+8d-pi: 4 mg ondansetron pre-incision + 8 mg dexamethasone pre-incision, 4o-pi+8d-pe: 4 mg ondansetron pre-incision + 8 mg dexamethasone pre-emergence, 4 o-pe+8d-pi: 4 mg ondansetron pre-emergence + 8 mg dexamethasone pre-induction, 4 o-pe+8d-pe: 4 mg ondansetron pre-emergence + 8 mg dexamethasone pre-emergence), and placebo group 2 ml saline 0.9%. primary outcome will be the incidence of ponv in the pacu prior to discharge.

Eligibility criteria:
inclusion criteria: * asa grade i and ii * aged 18-70 years * patients scheduled for elective surgery under general anesthesia exclusion criteria: * all patients who received antiemetics or cortisone within 48 hr before surgery * pregnant, breast feeding ladies * any patient with bmi (body mass index) \> 34 kg/m² * patient with gastrointestinal, hepatic, renal, mental or psychiatric illnesses were also excluded from the study protocol.

Keywords: nausea vomiting postoperative dose adjustment
study of smoking trajectory in newly diagnosis lung cancer patients

Conditions: Newly Diagnosed Lung Cancer; Smoking, Cigarette; Survival; Quality of Life

Summary: 1. understanding the smoking change patterns among the newly diagnosis lung cancer patients after cancer diagnosis. 2. explore the related factors of the smoking change patterns. 3. the type of smoking trajectory impact on survival and quality of life.

this was a prospective longitudinal design study. the investigators used the structure questionnaires to collect the data from a consecutive sample of newly diagnosed lung cancer patients.

Eligibility criteria:
inclusion criteria: * over 20 years old * newly diagnosed lung cancer * conscious clear and able to communicate * agreed to participate the study exclusion criteria: * consciously confused * cognitive or psychotic disorders

Keywords: smoking lung cancer survival quality of life
retinal nerve fiber layer thickness and macular thickness in myopia, hyperopia and emmetropia : an oct study

Conditions: OCT Study RNFL and Macular Thickness

Summary: the purpose of this study is to investigate the variability of rnfl and macular thickness between myopia , hyper metropia and emmetropia

the world health organization (who) has estimated that the visual impairment caused by uncorrected refractive errors to be present in 153 million people worldwide (1) the prevalence of myopia ranges from 22.7% to 38.7% in large population study according to the who regions the estimated prevalence (ep) of hyperopia is 30.6% with the lowest ep in south east asia 2.2% and the highest ep in the americas 14.3% (2-3) during optic nerve development 2.85 million nerve fibers exist but by the third trimester we lose about 35% of these fibers (4) and the perpapillary retinal nerve fiber layer (rnfl) thickness will continue to decrease with advancing age (5). the relationship of the rnfl thickness with the refractive errors has been extensively investigated in adults and in children (6) and there was significant increase in the rnfl thickness in hypermetrope than in emmetrope and myope understanding the derminants that affect the rnfl reserve helps us in the diagnosis and monitoring of optic nerve diseases. in macular region the thickness measured through optocal coherent tomography oct shows high variability with value ranging from 190mm (centerpoint) to 389 mm (superior inner/nasal inner macula) (7) for both retinal and macular regions while decreasing in the retinal thickness has been reported with increasing age. different studies have shown racial differences in rnfl thickness (8) white race (9) and myopia which has high prevelance in east asian regions (10-12) have been associated with thinner rnfl (11) on the contrary asian or hispanic race has been associated with a thicker rnfl

Eligibility criteria:
inclusion criteria: * all individuals having similar type of refractive status in both eyes and with no known confounding factor affecting retinal intensity or cdva and willing to participate. exclusion criteria: * • eyes with amplyopia * patients having posterior segment pathology or media opacity * patients with history of glaucoma * history of retinal laser therapy * history of ocualr trauma * any medical disease that prevents patients from positioning on the device

Keywords: oct study
multi-drug resistant gram-negative bacteria and veno-venous extracorporeal membrane oxygenation (ecmo)

Conditions: Respiratory Distress Syndrome, Adult; Multi-antibiotic Resistance

Summary: veno-venous extracorporeal membrane oxygenation (vv-ecmo) is a life-support technique used in patients with most severe acute respiratory distress syndrome (ards). ards is a life-threatening form of respiratory failure associated with a mortality rate of approximately 40-45%.despite several studies confirming a real benefit of the use of ecmo in patients with ards who are unresponsive to conventional management, ecmo is still a complex and costly treatment that can be exposed to potential complications, such as nosocomial infections (ni).

noteworthy, the most frequent nis occurring during vv-ecmo are pneumonia (\>40%) and, secondly, blood-stream infections (3-18%). the situation is more challenging for gram-negative bacilli: more than one-half of the escherichia coli and more than one-third of the klebsiella pneumoniae isolates were resistant to at least one antimicrobial group. of note, an alarming increase in carbapenem resistance has been reported in several species, including k. pneumoniae (7.9% of isolates), p.aeruginosa (16.5% of isolates) and a. baumannii (\>30% of isolates). in fact, the isolation of mdros has been shown to be an independent risk of death and of subsequent infections not only in critically ill patients but also in those patients requiring vv-ecmo (mortality rate between 56-68%). however, data are still conflicting about the exact incidence of multidrug resistant organisms (mdro) during vv-ecmo and the impact on short- and mid-term outcomes.

Eligibility criteria:
inclusion criteria: * ards * vv-ecmo exclusion criteria: * pregnancy * age \< 18 * uncompleted records * survival \< 24h after ecmo connection

Keywords: ards multi-antibiotic resistance extracorporeal membrane oxygenation
probiotics in paediatric asthma management

Conditions: Asthma in Children

Summary: randomized controlled double-blind trial in a child population with allergic asthma and recurring wheezing, undergoing probiotic treatment with bifiasthm with the aim of assessing the reduction in asthma attacks.

allergic disorders have dramatically increased in prevalence over the past decade, particularly in developed countries, and primary prevention of allergic disease has proved an elusive goal. there is increasing evidence that the airway microbiome influences the development of wheezing and childhood asthma. probiotics are increasingly considered as a promising treatment for the correction of dysbiosis, reduction of systemic inflammation, and modulation of allergic diseases. the aim of this study is, therefore, to evaluate the efficacy of bifidobacterium breve b632 (dsm 24706) and lactobacillus salivarius ls01 (dsm 22775) in the prevention of asthmatic allergies in human subjects.

Eligibility criteria:
inclusion criteria: * the study will include all children aged 6 to 14, with slight and moderate persistent asthma according to gina 2015 criteria (asthma classification did not change in gina 2015 and 2016 guidelines), whether or not showing positive skin allergometric tests, as well as all children aged 2 yrs, 364 days to 5 years, 364 days, with recurring wheezing, whether or not diagnosed with asthma (positive and/or negative prick). exclusion criteria: * severe persistent asthma * known congenital or acquired immunodeficiencies * cystic fibrosis * chronic pulmonary diseases (bronchodysplasia) * age \< 1 yr, 364d and 14 yrs
autologous fat grafting versus subepithelial connective tissue graft for volume augmentation

Conditions: Alveolar Bone Loss

Summary: the aim of this study was to evaluate the effectiveness of autologous fat as a grafting material for soft tissue volume augmentation of localized horizontal ridge defects in humans.

a total of 20 patients having 26 localized horizontal ridge defects were recruited for the study from the patient pool at the dental clinics of the faculty of dentistry, alexandria university. ridge defects were divided into two parallel groups: test group: localized ridge defects were augmented using autologous fat grafting control group: localized ridge defects were augmented using conventional subepithelial connective tissue graft.

Eligibility criteria:
inclusion criteria: 1. patients had at least one localized horizontal ridge defect in a single tooth gap requiring soft tissue volume augmentation. 2. teeth in the defect area have been extracted at least 3 months prior to enrolment 3. all patients were systemically healthy 4. patients were non-smokers 5. patients had abdominal fat accumulation allowing liposuction 6. ability to understand the nature of the proposed surgery and ability to sign an informed consent form exclusion criteria: 1. general contra-indications to surgical procedures 2. pregnancy 3. systemic diseases like diabetes mellitus and autoimmune diseases 4. history of malignancy, chemotherapy or radiotherapy within the last 5 years 5. concurrent medication affecting mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs)
stimulation with wire leads to restore cough

Conditions: Spinal Cord Injuries; Spinal Cord Diseases; Paralysis; Central Nervous System Diseases; Cough; Trauma, Nervous System; Wounds and Injuries

Summary: the purpose of this trial is to determine the efficacy of spinal cord stimulation, using wire leads, to produce an effective cough in patients with spinal cord injuries.

patients with cervical spinal cord injuries often have paralysis of a major portion of their expiratory muscles - the muscles responsible for coughing - and therefore, lack a normal cough mechanism. consequently, most of these patients suffer from a markedly reduced ability to clear airway secretions, a factor which contributes to the development of recurrent respiratory tract infections such as pneumonia and bronchitis. expiratory muscles can be activated by electrical stimulation of the spinal roots to produce a functionally effective cough. the purpose of this trial is to determine if electrical stimulation of the expiratory muscles by wire leads is capable of producing an effective cough on demand. according to the trial researchers, if successful, this technique will prevent the need for frequent patient suctioning - which often requires the constant presence of trained personnel. it will also allow spinal cord injured patients to clear their secretions more readily, thereby reducing the incidence of respiratory complications and associated illness and death. in the trial, researchers will study 16 adults (18-75 years old) with cervical spinal injuries (c8 level or higher), at least 6 months following the date of injury. after an evaluation of medical history, a brief physical examination, and initial testing, participants will have wire leads placed - by a routine, minimally invasive surgical procedure - over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough.

Eligibility criteria:
inclusion criteria: * spinal cord injury c8 level or higher * 12 months post-injury (if the american spinal injury association (asia) impairment scale (ais) incomplete) or 6 months post-injury (if ais complete) * expiratory muscle weakness * between 18 and 75 years of age * adequate oxygenation exclusion criteria: * untreated lung, cardiovascular or brain disease * scoliosis, chest wall deformity, or marked obesity * unmanaged hypertension (high blood pressure) or hypotension (low blood pressure) * low oxygenation * minor infection at the site of implantation requiring antibiotics within the past 3 weeks * serious infection requiring hospitalization within the past 6 weeks

Keywords: spinal cord injury paralysis cough cervical spinal cord injury thoracic spinal cord injury